Medical device licence · 80347 · Class 3
SPEEDSCREW KNOTLESS IMPANT
Yes: licensed in Canada
Licence status Issued (active); first licensed August 4, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80347
- Licence holder
- Arthrocare CorporationAustin, TX, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- August 4, 2009
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AUTOCUFF SPEEDSCREW KNOTLESS FIXATION DEVICE
- OPUS AUTOCUFF SPEEDSCREW KNOTLESS FIXATION DEVICE
- SPEEDSCREW BLUNT OBTURATOR
- SPEEDSCREW INSERTION GUIDE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.